β-blockers Withdrawal in Patients With HFpEF and Chronotropic Incompetence: Effect on Functional Capacity (Preserve-HR)

• Status: Completed
• Trial end date: 2021-02-27
• Target enrollment: 0
• Participant gender: All

Summary

The pathophysiology of heart failure with preserved ejection fraction (HFpEF) is complex and multifactorial. Chronotropic incompetence has emerged as a crucial mechanism, particularly in elderly patients. Betablockers, drugs with negative chronotropic effect, are commonly used in HFpEF, despite current evidence does not support its routine use in these patients. The aim of this work is to evaluate the effect of betablockers withdrawal in patients with HFpEF and chronotropic incompetence on functional capacity assessed by the peak oxygen consumption at maximal exercise (peakVO2) at 15 and 30 days after the intervention

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
• Treatments: Adrenergic beta-Antagonists

Criteria

Inclusion Criteria:

• Stable symptomatic patients with heart failure and preserved ejection fraction (NYHA class II-III).

• NT-proBNP >125 pg/mL in the last month

• Previous treatment with beta-blockers during the last 3 months

• Documented chronotropic incompetence, defined as: [(heart rate at peak exercise- heart rate at baseline)] / [(220 - age) - (heart rate at baseline)] < 0.62

Exclusion Criteria:

• Moderate to severe valvulopathy or miocardiopathy associated

• Patient with heart failure with recovered ejection fraction

• Acute Coronary Syndrome in the previous 12 months

• Angina or signs of myocardial ischemia on cardiopulmonary exercise testing

• Baseline heart rate>75 bpm.

• Uncontrolled hypertension, defined as >140mmHg systolic blood pressure and/or >90 mmHg diastolic blood pressure.

• Moderate to severe pulmonary disease associated

• Extracardiac comorbidity with a life expentancy less than 1 year.

• Unable to perform an adequate cardiopulmonary exersice test

• Previous treatment with digitalis or calcium channel blockers